European Regulatory Language Requirements

Sustaining competitive advantage within the				MaltesePoland - PolishRomania - RomanianSlovakia
medical device industry involves a global product				- SlovakSlovenia - SlovenianTurkey - TurkishEU
strategy that recognizes the European market's				Member State Official Languages
substantial global market share. Estimated at 30%				Depending on the extent of the product's
of the global medical device market, the European				presence in the European Union, there are
community poses increasing regulatory challenges				currently up to 12 languages required for the
for medical device manufacturers. Regulations				labeling, IFUs, documentation, and marketing
controlling the manufacturing, marketing and usage				materials in accordance with the IVDD and MDD
of medical devices in the EU are forcing				necessary for CE mark as displayed in TABLE I
manufacturers to incorporate language translation				.As the EU continues to grow and the trading
and localization into global development strategies				barriers dissolve, prospective Member States are
as individual Member States demand product				actively transitioning regulations to meet the CE
information in the language of the local user.An				mark criteria, requiring new languages. A midday
exigent regulatory hurdle facing the medical device				regulatory shadow to the EU, European Free
industry is the European Union's IVDD 98/79/EC				Trade Association (EFTA) countries of Iceland,
directive which went into effect December 7,				Liechtenstein and Norway are aggressively
2003. Formulated five years ago, the IVDD 98/79				enforcing the CE mark, shown in TABLE II .
EC dictates that as of the December date, all				Although not a member of the EFTA, Switzerland
new in vitro medical devices must bear CE Marks				is also enforcing medical device CE mark.In
or face refusal into the European market or				addition to the EFTA, 13 more countries have
regulatory, criminal or product/civil liability.What is				applied for membership in the European Union.
the guiding principle behind the new directive?The				Performing a parallel migration to the European
IVDD Directive virtually eliminates the costly				Union's regulatory requirements, several of these
regulations imposed by individual member states.				future Member States are actively adopting the
Manufacturers who comply with the Directive will				CE Mark to ensure goods can freely move
be able to apply the CE mark to their products				throughout the European Union, including Poland,
and market them freely within member states of				Romania, Slovakia, and Turkey, seeTABLE III .
the EU.				Global Harmonization and International Quality
The IVDD (In Vitro Diagnostic Devices Directive)				Standards
is one of three associated directives issued by the				In 1998, the United States and the European
European Union, which together cover all forms of				Union introduced the New Transatlantic
medical equipment with the intent to ensure that				Agreement (NTA) to improve economic
only safe and effective products are sold in the				cooperation between the two economic powers.
European market. The directives clearly outline				In this landmark accord resides the Mutual
regulations regarding manufacturing, importing, and				Recognition Agreement (MRA) that acknowledges
marketing of such devices. The IVDD specifically				the regulatory standards of the respective
involves in vitro ( in an artificial environment				economic bodies-an area of transition that affects
outside the living organism ) medical devices that				the medical device industry. The European Union
examine human fluids or tissue samples to				medical device directives refer to ISO 9001 as
identify, diagnose, and monitor medical conditions.				the series of quality management standards and
The IVDD 98/79/EC brings in vitro devices in line				the US refers to FDA's Quality System
with other medical devices already regulated by				Requirements and all corresponding good
the EU, the MDD (Medical Devices Directive) and				manufacturing (GMP) practices regulations.
the AIMDD (Active Implantable Medical Devices				Benefiting medical and pharmaceutical companies,
Directive).The IVDD and it sibling directives apply				both quality systems have made considerable
progressive regulatory requirements to medical				efforts to synchronize their requirements further
devices and their accessories depending on the				increasing the common ground between quality
classified risk they present to the user, defined in				systems in North America and Europe.ISO
the directive as Class I through III. Unless the				(International Organization for Standardization)
classified product is a low-risk Class I device that				Adding to the pressure the current ISO
does not contain any sterile packaging or a				9000:1994 standard is transitioning to a new ISO:
measuring function, manufacturers require a				9000:2000 series effective December 14th of this
third-party Notified Body to independently certify				year. However, as of May 15, 2003, only 19.5%
the device's compliance to the Directive's Essential				of the total ISO registered North American
Requirements (a.k.a. Annex I)-good faith is not				companies had completed their registration
enough. Additionally, in a new twist within the				process. This is essential in the entire chain of
Directive, the authorized representative shown on				requirements. The new standard is a consolidation
the device label for Class I devices manufactured				of ISO 9001 and 9002, and has more of a
outside the EU may be required to produce the				customer satisfaction and continuous
technical file, including copies of all translated				improvement focus not present in previous
materials. Any incorrect labeling or instructions for				versions.GMP (Good Manufacturing Practices)
use may lead to regulatory criminal or product				In December 1978, the FDA Good Manufacturing
civil liability in the EU.Any medical device				Practices (GMP) Regulation became effective,
manufacturer wishing to market its products in				establishing Quality System Requirements for
the European Union is fully responsible for				products regulated under the FDA, including
complying with the corresponding safety and				medical devices. In 1990, the Safe Medical Devices
administrative Essential Requirements and must				Act (SMDA) expanded the GMP to include design,
display the CE mark of conformity as stated in				manufacturing, packaging, labeling, storage,
Article 16 of the IVDD 98/79/EC . If that's not a				installation and servicing of all finished medical
red flag, consider the next regulatory deadline				devices.Exporting American Medical Devices
facing in vitro device manufacturers: By				Any medical device in the US market may not
December 7, 2005, the European Union will not				be legally exported anywhere in the world without
only require a CE mark to legally market a				prior FDA notification or approval; however, for a
product, but will require a CE mark to legally put a				device to be legally distributed in the US, the FDA
medical device into service-a requirement much				requires:
more critical to the revenue of manufacturers				Registration of both the medical device and
and healthcare!CE Mark: A passport to the				manufacturing site- Authorization for commercial
European Union				distribution through either a 510(k) pre-market
An abbreviation of a French phase "Conformite				notification or a Pre-market Approval (PMA)
Europeene," the CE mark indicates that the				application depending upon the classification of the
medical device manufacturer has conformed to all				device- Compliance with FDA labeling
the obligations set forth by the Directive 98/79				requirements- Manufacturing compliance with the
EC of the European Parliament. Affixing this				FDA's GoodManufacturing Practices (GMP)While
multinational standardized mark to a product will				the FDA does not place any restrictions on the
allow any global manufacturer a "passport" to				export of these devices, certain countries require
freely distribute their products within the European				an Export Certificate that the manufacturer and
Union without additional quality testing or				its devices are indeed in compliance with FDA
approvals. Reflective of the 1946 Treaty of				regulations. Medical devices that do not have a
Rome, the CE mark is a conformity tool that is				510(k), PMA, or are solely manufactured for
intended to further promote the establishment of				export may by approved for exportation by the
a single market where the free movement of				FDA through Section 801(e)(1) of the FFDCA;
goods, persons, services and capital are ensured.				however, the manufacturer may experience
Fundamentally, the CE mark and the medical				regulatory difficulties depending on the individual
device directives remove many regulatory hurdles				country's requirements of an FDA Export
while providing stronger regulations for smaller				Certificate, which, as stated above, require a 510
countries; however, it also creates critical language				(k) or a PMA.Sorting through the regulations to
compliance issues that may prove to be costly				achieve global product delivery
for manufacturers. Regardless of the intended				The question facing medical device
global harmonization, participating countries are				manufacturers in the current global market is how
preserving their national cultures and languages by				to meet all language requirements in the most
requiring product information in their own local				cost-effective, regulatory compliant manner.
languages.IVDD, MDD & AIMD...more languages!				Managing regulations and translations are among
Depending on device classification, to legally				the most critical aspects of developing and
display the CE mark, the IVDD, MDD, and AIMD				marketing products for the life sciences industries.
all mandate that manufacturers provide all labeling,				Any mistake, no matter how minor, can delay
information for usage, documentation, and				product approvals, launches, or cause widespread
marketing materials in the official language(s) of				public relations disasters. Therefore, developing
the end-user's Member State, taking into account				translation and localization processes has become
the training and knowledge of the potential users				a competitive advantage for global manufacturers
as stated in Article 4, Paragraph 4, IVDD 98/79				of medical devices.Working closely with a
EC .Documentation Translation Requirements -				translation and localization vendor who specializes
Conformity Assessment Procedures				in medical language services is an important step
Manufacturers are required to translate the				in conquering the ever-changing international
documentation relating to the production, testing				regulatory process. The choice of the translation
and quality processes in the official language(s) of				provider is extremely important to ensure that
the Member State in which the procedures are				translations are accurate, consistent and
carried out as stated in Article 9, Paragraph 11 of				technically correct, as well as harmonious with the
the IVDD 98/79/EC. Depending on device				manufacturers' processes.Medical language service
classification, these documents must include a				providers should-at the very least-provide
number of required disclosures dependent on the				documented processes that involve
product classification.				native-speaking linguists that have expertise in
Depending on marketing and distribution				both medical translation and the medical industry.
objectives, some products may require up to 12				To deliver consistency, quality and reduced costs,
languages, creating complicated multilingual product				the language service provider should also
labeling and IFU challenges. There can be over 20				implement terminology management tools and
information pieces required for each product label				computer-assisted translation solutions in concert
of IFU, depending on the classification as detailed				with the team of human translators.Conclusion
in Annex I, Part B, Section 8 of the				Complex and ever-changing international
Directive.Table I				regulations controlling the marketing and usage of
Official Language(s) of EU Member				medical devices are forcing manufacturers to
StatesMember State Official language(s)Austria -				incorporate language translation and localization into
GermanBelgium - Dutch, French &				global development strategies. The European Union
GermanDenmark - DanishFinland - FinnishFrance -				members currently require that all product
FrenchGermany - GermanGreece - GreekIreland -				information be in the official language of the local
EnglishItaly - ItalianLuxembourg - French, German,				users and the diversity of this economic area is
LuxembourgishNetherlands - DutchPortugal -				only growing to include more regulations and
PortugueseSpain - SpanishSweden -				official languages. A simultaneous global release of
SwedishUnited Kingdom - EnglishTable II				medical devices involving up to 12 languages in
Official Language(s) of EFTA Member States				Europe alone makes this issue as critical as the
Member State Official language(s)Iceland -				intended purpose of the medical device.
IcelandicLiechtenstein - GermanNorway -				Medical device manufacturers can
NorwegianSwitzerland - German, French & Italian(				cost-effectively market their products globally
Switzerland is not a EFTA member but requires				while satisfying international regulatory
translation)Table III				requirements by partnering with Net-Translators a
Official Language(s) of Member States Applying				qualified language service provider in the very
For EU Membership				early stages of product development. The right
Member State Official language(s) Bulgaria -				language partner can turn what may now appear
BulgarianCyprus - GreekCzech Republic -				as a chaos of regulatory requirements into a
CzechEstonia - EstonianHungary - HungarianLatvia				successful international product release.
- LatvianLithuania - LithuanianMalta - English &

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European Regulatory Language Requirements